EudraVigilance services

Our services along the whole product lifecycle

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Discover all our Pharmacovigilance services

Drug Development Regulatory Affairs Market Access Pharmacovigilance Quality & Compliance Case Studies

Drug Development

Drug Development Strategy Gap Analysis SME Status Orphan Drug Designation (ODD) Scientific Advice Pediatric Investigation Plan (PIP) PRIME (PRIority MEdicines) scheme CMC Regulatory solutions Clinical Trial Application (CTA) Due Diligence

Regulatory Affairs

Registration Strategy Marketing Authorization Application (MAA) CMC Regulatory solutions Dossier Development Life cycle management Due Diligence Launch readiness Advertising & Promotion

Market Access

Early Access Programs Market Access Strategy Pricing & Reimbursement Dossier Health Economic Models Negotiation with Health Authorities Pricing & Reimbursement maintenance Joint Clinical Assessment (JCA) Integrated strategy and execution in the European markets

Pharmacovigilance

QPPV Services EudraVigilance services Pharmacovigilance System Master File (PSMF) Local Pharmacovigilance

Quality & Compliance

EMA’S DATA PROCESSING NETWORK AND MANAGEMENT SYSTEM

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a data processing network and management system operated by the European Medicines Agency (EMA) on behalf of the European Union (EU) medicines regulatory network.

Its scope encompasses both investigational drugs and marketed products.

Marketing Authorization Applicants (MAAs), Sponsors, and Marketing Authorization Holders (MAHs) are required to register in the system and maintain specific key data points.

Sponsors and MAHs can use EudraVigilance to manage and submit Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during clinical trials, the authorization period, or through data submission (Article 57/xEVMPD). The system also supports the detection and monitoring of safety signals, safety data analysis, and reporting through the EudraVigilance Data Analysis System (EVDAS) interface.

RPN’s EudraVigilance services include:

Creation and management of the client’s EudraVigilance account.
Updating the organization’s data as required.
Assistance in setting up gateway transmission to connect with the EMA.
Regulatory submission of ICSRs.

RPN can guide the company through the entire EudraVigilance setup process and facilitate the transfer of the QPPV and/or Responsible Person functions from previous providers, if necessary.

Pharmaceutical & BioTech